California state laws and regulations that affect your medical practice
I. DISPENSING MEDICATION
1. What are the specific restrictions on the dispensing of medication from a medical office?
Under California law, a prescriber cannot dispense drugs to patients in his/her office unless certain conditions are met. Before a prescriber can dispense a drug/dangerous device, he/she must emphasize, in writing, that the patient may either obtain the prescription from the prescriber or a pharmacy. Drugs/dangerous devices must be dispensed to the prescriber’s own patient (and may not be given by a nurse or physician attendant) and must be necessary for treatment of a particular condition. (A “prescriber” is defined as an individual who has a physician’s and surgeon’s certificate, license to practice optometry, license to practice naturopathic medicine, license to practice dentistry, license to practice veterinary medicine, or certificate to practice podiatry registered by the respective boards in California).
Other restrictions include that the prescriber cannot own a pharmacy for the retailing of drugs or dangerous devices. The prescriber must also fulfill labeling requirements imposed on pharmacists, record keeping requirements, and packaging requirements (e.g., childproof containers). Additionally, the prescriber cannot use a dispensing device unless he/she owns it and its contents personally and the device meets the same requirements for state laws pertaining to pharmacists.
The law does not prohibit a prescriber from dispensing samples, as long as the samples remain in the manufacturer’s packaging; the patient is not charged for the samples; and the transaction is recorded in the patient’s chart.
Cal. Bus. & Prof. Code § 4170(a)-(c)
2. May a physician charge for medication distributed in a medical office?
California law is silent on whether a physician may charge for medication distributed in his/her medical office, so such a practice does not appear to be prohibited. However, the law specifically notes that a physician cannot charge a patient for samples provided to the patient in manufacturer’s packaging.
Cal. Bus. & Prof. Code § 4171(a)
3. Other than a physician, who can dispense medication in a medical office setting?
A certified nurse-midwife, a nurse practitioner, a physician assistant, or a naturopathic doctor is allowed to hand the properly labeled prescription drug to the patient of the supervising physician, as long as the drug has been prepackaged by a physician and surgeon, a manufacturer, or a pharmacist.
Cal. Bus. & Prof. Code § 4170(a)(8)
4. What information must physicians provide on a prescription?
California requires that the following information be included on all prescriptions:
A. Either the manufacturer’s trade name of the drug or the generic name and the name of the manufacturer;
B. Directions for use of the drug;
C. The name of the patient or patients;
D. The name of the prescriber;
E. The date of issue;
F. The name and address of the pharmacy, and prescription number or other means of identifying the prescription;
G. The strength of the drug or drugs dispensed;
H. The quantity of the drug or drugs dispensed;
I. The expiration date of the effectiveness of the drug dispensed;
J. The condition for which the drug was prescribed if requested by the patient and the condition is indicated on the prescription; and
K. The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules
L. For any quantity of dimethyl sulfoxide (DMSO), prescribed by a physician or dispensed by a pharmacy pursuant to a physician’s order, the following notification must be affixed: “Warning: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you.”
Cal. Bus. & Prof. Code §§ 4076(a)(1)-(11), 4077
5. Are there any restrictions regarding the dispensing of medication received as "free samples"?
The physician may dispense a limited quantity of samples to a patient, provided that the physician adheres to the following:
A. The samples must be dispensed in the package provided by the manufacturer;
B. The physician cannot charge the patient for the samples; and
C. An appropriate record must be entered in the patient’s chart.
Cal. Bus.& Prof. Code § 4171
II. PRESCRIBING OF SCHEDULED DRUGS
1. Requirements for prescribing controlled substances?
A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual physician acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing physician, with a corresponding duty upon the pharmacist who fills the prescription.
The following are not legal prescriptions:
A. An order purporting to be a prescription which is issued not in the usual course of professional treatment or in legitimate and authorized research.
B. An order for an addict or habitual user of controlled substances, which is not issued in the course of professional treatment or as part of an authorized narcotic treatment program, for the purpose of providing the user with controlled substances, sufficient to keep him or her comfortable by maintaining customary use.
Cal. Health & Safety Code § 11153
2. In what form must prescriptions for controlled substances be written?
All prescriptions for controlled substances must be obtained from security printers approved by the Department of Justice. The prescription forms must be printed with features including, but not limited to:
A. A “void” pattern must be printed across the front of the prescription, so that if scanned or photocopied, the word “void” will appear.
B. A watermark shall be printed on the back of the prescription with the words “California Security Prescription.”
C. A chemical void protection that prevents alteration by chemical washing
D. A feature printed in thermo-chromic ink
E. An are of opaque writing so that the writing disappears if the prescription is lightened
F. A description of the security features included on each prescription form.
Every prescription for a controlled substance in Schedule II shall be made using the above form and must meet the following requirements:
A. The prescription must be signed and dated by the prescriber in ink and shall contain the prescriber’s address and telephone number
B. The name of the person for whom the controlled substance is prescribed
C. The name, quantity, and directions for use of the controlled substance prescribed
D. The address of the person for whom the controlled substance is prescribed
E. The date of issue and the prescription and all of the information required for a written prescription must be included in the written record
Cal. Health & Safety Code § 11161.5, 11162.1, 11164
3. How long is the prescription valid?
A physician may dispense to a patient a controlled substance in an amount not to exceed a 72 hour supply, where the patient is not expected to require an additional amount of the controlled substance beyond the 72 hours.
4. What are the requirements of prescriptions for different categories of controlled dangerous substances?
The requirements depend upon the schedule under which the controlled substance is categorized. The following will address the requirements based on schedule classifications.
A. Schedule II (S-II)
(1) When can a physician prescribe a Schedule II drug?
Physicians prescribing Schedule II drugs are subject to certain restrictions under the Uniform Controlled Substances Act. First, a physician may only issue a prescription for a controlled substance if it is issued for a legitimate medical purpose and issued during the usual course of his/her professional practice. Additionally, a physician may not prescribe a controlled substance to an addict or habitual user.
A physician may dispense a Schedule II controlled substance to a patient provided it does not exceed a 72 hour supply, where the patient is not expected to require an additional amount of the controlled substance beyond the 72 hours.
An order for controlled substances for use by a patient in a county or licensed hospital will be exempt from the above requirements; however, the following are required:
(a) The order must be in writing on the patient’s record;
(b) It must be signed an dated by the prescriber;
(c) It must state the name and quantity of the controlled substance ordered and the quantity actually administered; and
(d) The record of such orders must be maintained as a hospital record for at least 7 years.
Cal. Health & Safety Code §§ 11153, 11156, 11158
(2) What are examples of Schedule II drugs which fall under this regulation?
The following list provides an example of many of the generic and brand-name Schedule II drugs which fall within the above regulation:
Cal. Health & Safety.Code § 11055
(3) What are the potential penalties for violating this regulation?
Any person who knowingly violates this section or has a conscious disregard for the fact that the controlled substances are for other than a legitimate medical purpose will be subject to:
(a) Imprisonment in the state prison or in the county jail not exceeding one year; or
(b) By a fine not exceeding twenty thousand dollars ($20,000); or
(c) By both a fine and imprisonment
Cal. Health & Safety Code § 11153
B. Schedule III (S-III), Schedule IV (S-IV), Schedule V (S-V)
A physician or an agent authorized by the physician may orally or electronically transmit a prescription for a controlled substance classified in Schedule III, IV, or V (if the written record of the prescription identifies the name of the agent of the prescriber writing the prescription).
Cal. Health & Safety Code § 11164
5. What are the requirements for the refilling of prescriptions?
A physician is prohibited from refilling a controlled substance prescription more than six (6) months after the date issued.
A. Schedule II (S-II)
The refilling of a prescription for a controlled substance listed in S-II is prohibited.
B. Schedule III (S-III) and Schedule IV (S-IV)
No prescription for a Schedule III or IV substance may be refilled more than five (5) times and in an amount, for all refills of that prescriptions taken together, exceeding a 120-day supply.
Cal. Health & Safety Code § 11200
Copyright © Kern Augustine Conroy and Schoppmann, P.C. Used with permission.